Life Sciences and Healthcare
Life Sciences and Healthcare in every country continues to evolve, and each healthcare regime has complex regulatory environments, growing competition, developing technologies, extended supply chains, and profitability pressures. Our small, senior teams collaborate with medical device, pharmaceutical, biotechnology companies, as well as healthcare providers and payors, to better manage issues, maintain and improve profitability, and stay ahead of the changing industry landscape. We have decades of experience to help you address the challenges involved with disputes, complex transactions, talent management, outsourced and strategic partnerships, compliance, investigations, or operations. The following are specific services we have provided to companies in the Life Sciences and Healthcare industry:
Expert Witness
Our team has experience in serving as arbitrators, testifying experts and consulting experts in a variety of disputes including those involving:
- Commercially reasonable efforts, licensing, running royalties and M&A escrow contract terms
- Industry practice, fraudulent conveyance, accounting, transfer pricing, intellectual property value, and associated damages
- Failure to supply and associated breach of contract allegations
- Accounting treatment, overhead calculations, and associated damages among global companies
- Allegations of fraud, missed milestones, patient recruitment rates, and violations of cGCP
- Assessing damages using event studies, times series, and other statistical methods
- Market valuations and licensing in the brand and generic pharmaceutical sectors
- Parallel trade and antitrust exposure
- Business interruption, alleged wrongful termination, and associated damages
- Alleged dilution of brand, improper distribution, insufficient sales efforts
- Wage and hour, as well as other related labor / discrimination matters
Operations
Our team has hands on operations, finance, and accounting experience involving a host of corporate issues, such as:
- Evaluating and improving remediation efforts, plans to return to market, and go-forward financial strategy for companies under an FDA Consent Decree
- Assessing and re-engineering payor management operations to increase annual cash generation and to increase efficiencies
- Evaluating compliance with best price provisions within multiple GPO and PBM contracts, including associated policies, operations, and transactions
- Assessing supply chains for vulnerability to misappropriation of assets and profit dilution
- Evaluating intellectual property commercialization processes from R&D through enforcement in multiple countries including the US, the EU, China, Japan and Korea
- Assessing gross revenue to net revenue processes, procedures, and organization design to minimize profit dilution
- Managing intellectual property issues and the unauthorized use of secondary/grey markets by third and fourth parties
- Evaluating product launch, asset acquisition, finance and supply chain strategies to minimize risk and profit dilution
Investigations
Our global experience with internal, bribery, third-party, and fourth-party due diligence and investigations helps us provide results effectively and efficiently. The following are examples of our experience:
- Creating, managing, and executing third and fourth-party risk management programs and, when needed, investigations involving regulatory and contract compliance
- Conducting due diligence involving several joint development agreements to evaluate commercially reasonable efforts and compliance with agreement provisions
- Executing internal investigations involving CIAs and DPAs, and evaluating associated compliance programs and operational processes, for sales call planning, sales force management, and off-label marketing
- In the context of settlements with the DOJ and the SEC, analyzing revenues, distribution models, financial and physical flows, and market events in multiple countries to estimate potential profit disgorgement
Regulatory and Compliance
Our team has worked on some of the most sensitive and important matters involving US and global regulatory issues and internal policy violations, such as:
- Working with internal and external counsel to coordinate issue reporting to the IROs, the OIG, and State Attorney Generals
- Negotiating settlements with State AGs in the context of multidistrict litigation
- Providing services involving affirmative action plans, pay equity, and OFCCP audits
- In conjunction with external counsel, performing pre-IRO testing of sales representative interactions involving speaker programs and HCP meals
- Working with external counsel to evaluate adherence to FDA promotional guidelines and implementing modified protocols by reviewing the associated operations, systems, and regulatory filings
- Evaluating compliance programs, identifying areas for improvement, as well as creating compliance monitoring and analytics programs for investigator initiated trials and advisory boards
- In conjunction with external counsel, evaluating patient assistance programs, policies, and associated transactions
